NCT07696182尚未招募不适用
VOYAGER CE Clinical Trial : Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Composite of all-cause mortality or all strokes at 12 months post index
研究概览
简要总结
VOYAGER CE Clinical Study using the Encantor TAVI System.
详细描述
The VOYAGER CE trial is a prospective, single-arm, multi-center, pre-market clinical investigation designed to evaluate the safety and performance of the Encantor TAVI System. This clinical trial will enroll subjects who have symptomatic heart disease due to severe native calcific aortic stenosis and who are judged by a heart team to be appropriate for transcatheter valve replacement therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject identified as appropriate for transcatheter heart valve intervention therapy for the treatment of symptomatic, severe aortic stenosis.
- •Subject is of legal age for consent (18 years old).
- •Willing to return for required follow-up visits and assessments
排除标准
- •Pregnant or nursing subjects.
- •Need for emergency surgery for any reason
- •Anatomic or comorbid conditions
- •Currently participating in an investigational drug or device study that has not reached the primary endpoint or may confound the results of this trial
结局指标
主要结局
Composite of all-cause mortality or all strokes at 12 months post index
时间窗: 12 months post index
Composite of all-cause mortality or all strokes
次要结局
未报告次要终点
研究者
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